PharmaSUG China 2016 - Paper 71 PPG, a metadata driven solution for patient profile generation Weina Jia, Sanofi, Beijing,China Eric Li, Sanofi, Beijing,China Vincent Fan, Sanofi, Beijing,China Yihong Chi, Sanofi, Beijing,China Qingan Chang, Sanofi, Beijing,China
ABSTRACT To facilitate the medical review, data management programmer need to provide the patient profile (PP) to medical reviewer. In most cases, delivering a set of PP for one study takes at least 5 days as data manager need to prepare its specification and then the programmer need to develop the SAS code accordingly. But with PP Generator (PPG), specification preparation and routine programming are not needed any more. It will create PP based on RAVE study design specification (SDS) and source data extracted from clinical database directly, minimize the mistake you might make and greatly reduce repetitive programming, so as to improve the programming efficiency and accuracy and save development time ( taking no more than 3 hours). PPG also has the flexibility by providing the interface for PP population, context, styles and format customization to meet data manager’s individual demands while reviewing.
INTRODUCTION PP is individualized patient data for medcial review, it includes a big amount of tables and variables in a study, while each table could contain some aspects of information. Most of cases, it need Data Manager provide a very detail specificaiton and send to SAS programmer, then SAS programmer manually program the PP table by table per this specification. For Data Manager, it’s really a grueling work as it need to write a very detail specification for a proposal layout. For SAS programmer, a lengthy SAS programming effort will be involved. Both the specificaiton and the program for one study are usaully not reusable for another study. It would be time consuming and error prone for both Data Manager and SAS programmer. For RAVE-EDC system studies, with PPG, PP could automatically created. No additional specification and programming needed. As long as the SDS and source data are ready, PPG could create a specificaiton in EXCEL format all by itself. Then Data Managers go to fill the parameters in the PP specification to customize the PP as what they want. By simply using one command button, PP can be automatically created.
WHAT IS PPG SDS is downloaded from RAVE-EDC system. It contains e-CRF structure data such as Forms, items, label, order and sequence information. PPG is a generic SAS mcaro package used to create PP based on SDS and source data extracted from clinical database.
WHAT IS PPS PPS is the patient profile specification created by PPG based on SDS, and also the centralized configure file for PP output customization, it will determine: What data will be displayed in PP How clinical data structured and render in the PP The style and format of the PP The population of the PP Some other aspects of the PP
THE INTERFACE OF PPS PPS is composed with the following six sheets: INSTRUCTION, PARAMETER, POP, DOMAIN, FORM and FIELD. PARAMETER and POP are used to control the parameter and population at study level. DOMAIN, FORM and FIELD are used to customize PP output context and style for study specific requirement.
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Instruction sheet INSTRUCTION is the precaution that contains the rules and constraints of configuring the PPS.
Parameter sheet PARAMETER contains the parameters at study level. It will apply to all patients. For example, if the table is empty and not expected in the PP output, “N” could be filled in “Value” column under “SHOW EMPTY TABLE” parameter, then only the tables which have records would be displayed in the output.
Display 1. Matrix Interface of Parameter
Pop sheet POP contains all the predefined population list at study level, Data Manager could choose one or more population at the same time, the relationship among the populations could be defined via “MULTIPLE FILTER MODE” on PARAMETER sheet. If none of the populations meet Data Manager’s needs, SAS programmer could derive a program to generate a population and fill the “Customized POP” parameter on POP sheet.
Display 2. Matrix Interface of Pop
Domain sheet DOMAIN sheet contains all the domains the study involved. The relative position of each table in PP output could be controlled by “Order” column. The domain label which appear into the bookmark of output could be definded by “Label” column. Meanwhile, the appearance of domain level table(s) could be controlled by “Display” column. For example, very frequently, Data Manager also request a sub-PP for dedicated review, via “Display” column, Data Manager could choose the tables only they want.
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Display 3. Matrix Interface of Domain
Form sheet FORM sheet contains all the forms the study involved. The relative position of forms within one domain, the form title, footnoot, the displaying of the forms could be controlled by “Order”, “Title”, “Footnote”, “Display” columns. Meanwhile, the “sort” column could indicate the sorting variable(s) for the form. If Data Manager want to filter the records within one form, it could be customized by “Restriction” column. For example, if only serious AE would be considered, it could be filled as “AESER= ‘Y’”. If the form need transpose, it could be customized by “Transpose” as “Y”.
Display 4. Matrix Interface of Form
Field sheet FIELD sheet contains all the variables for each form. The relative position of all variables within one form, the label of each variable, the width of each variable in PP output, the displaying of each variables could be customized by “Order”, “Label”, “Width”, “Display” columns. For “Define” and “Compute”, they follow the same syntax as report procedure. For example, add format of variables could be fulfilled by “Define”, highlight raws, columns which meet some conditions could be defined via “Compute”.
Display 5. Matrix Interface of Field
FEATURES AND FUNCTIONALITY PPG has the following features. Meta data driven, based on the SDS from RAVE. PPG with its customization function is robust and applicable for all studies on RAVE. Programming and specification are not required if no study specific requirement.
PPG has multiple useful functions. The customization function can help users with controlling the output for his/her purpose. The highlight function can highlight the data that created or modified between the START_DATE and END_DATE that users specified in the PPS. PPG can use multiple population.
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PPG has two kinds of output: PDF and Word. PPG can retrieve the previous settings for the amendment of CRF.
TECHNICAL SOLUTION To automate the PP, PPG, a SAS macro package is created. User could generate the PP via simply submitting the ppg.sas program if no study specific requirement. For complicated requirment from Data Manager, the macros also provide the interfaces for customization.
PPG SAS MACRO PACKAGE COMPONENT The PPG tool is composed by 11 macros. Every macro has its special usage, every macro is also a important part of the whole chain.
%npp_create_pps This macro is used to create PPS based on SDS.
%npp_read_pps This macro is used to read PPS matrix information.
%npp_fresh_pps This macro is used to fresh PPS based on previous PPS, amended SDS and database. Also the difference between SDS and database would be indenified in the new PPS.
%npp_get_pop This macro is used to get the population predefined and also check the logic with “PARAMETER” sheet.
%npp_prepare_data_from_pps This macro is used to prepare active data for reporting.
%npp_report_byform This macro is used to generate PP by form order.
%npp_report This macro is used to generate PP by domain, then by form order.
%npp_pdf_style This macro defined the PP output style.
%npp_doc_restructure This macro is used for generating PDF output bookmark.
%npp_transpose This macro is used to transpose tables defined in PPS matrix.
%npp_ppg Include all the macros above to generate PP based on the condition.
PPG SAS MACRO LOGIC PROCESS After you run ppg.sas, PPG will detect if the PPS exists in the dedicated folder, if it does exist, PPG will generate a new PPS automatically according to the content of SDS. If it exists, PPG will identify the value of “REFRESH PPS”, if it is “Y”, then PPG will refresh the PPS base on SDS, if it is “N”, PPG will re-organizes and renders the patient data, then generate PP output automatically. The workflow of PPG can be shematically represented as below.
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Figure 1. Basic Algorithm of PPG
CONCLUSION This paper introduced PPG, a effective and reusable tool to generate patient profile as long as SDS is ready, without requiring additional programming and patient profile specification if no study specific requirement. Highly customized reports also could be created by configure PPS. We hope this methodology could help you saving time and resources for developing patient profile on all Rave studies.
REFERENCES SAS® 9.4 Macro LanguageReference Fourth Edition http://support.sas.com/documentation/cdl/en/mcrolref/67912/PDF/default/mcrolref.pdf
CONTACT INFORMATION Your comments and questions are valued and encouraged. Contact the author at: Name: Weina Jia Enterprise: Sanofi Address: HNA 3/F, No.108, Jian Guo Lu, Chaoyang District City, State ZIP: Beijing China 100022 Work Phone: (8610) 65634751 E-mail: [email protected]
SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ® indicates USA registration. Other brand and product names are trademarks of their respective companies.
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